MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number G25149

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket partially extended out of the catheter lumen.There was no fluid in the catheter lumen.One of the wires on the basket had broken loose from the distal end of the basket and was still attached at the proximal end of the basket.A production meeting was held on (b)(6) 2019, the distal tip of the wire was examined under magnification and it was determined that the wire had been damaged by the buff process.No part of the device was missing.No other anomalies were detected.The device history records for the wire guide lot was reviewed.The extraction basket device history record contains a nonconformance that could potentially be related to basket wire breaks.A record of notification was issued to production management and the department leaders in response to this report.Investigation conclusion: it was confirmed that the device was broken due to damage done to the basket wire during the buff process.This occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.Re-training with the operator was completed on (b)(6) 2019.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.The operator was retraining on the associated processes.No additional corrective action is warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

In preparation for an endoscopic procedure, the physician selected a cook memory ii double lumen extraction basket.Upon opening the package of the device, the user noticed that the basket wire was already broken.Therefore, another manufacturer's basket device was used instead.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8732626
• MDR Text Key: 152096100
• Report Number: 1037905-2019-00350
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)220405(10)W4200526
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4200526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1